CLAVERSAL 1000 mg Rectal Foam
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How to use CLAVERSAL ESPUMA RECTAL (Rectal Foam)
Contents of the leaflet
- Introduction
- What is Claversal rectal foam and what is it used for
- What you need to know before you start using Claversal rectal foam
- How to use Claversal rectal foam
- Use in elderly patients
- Possible side effects
- Storage of Claversal rectal foam
- Contents of the pack and further information
Introduction
Patient Information Leaflet
Claversal 1 g Rectal Foam
mesalazine
Read this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Claversal rectal foam and what is it used for
- What you need to know before you start using Claversal rectal foam
- How to use Claversal rectal foam
- Possible side effects
- Storage of Claversal rectal foam
- Contents of the pack and further information
1. What is Claversal rectal foam and what is it used for
Claversal contains mesalazine (also known as 5-aminosalicylic acid), which belongs to a group of medicines called intestinal anti-inflammatory agents.
Claversal rectal foam is indicated for the treatment of ulcerative colitis, an inflammatory disease of the intestine.
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2. What you need to know before you start using Claversal rectal foam
Do not use Claversal
- if you are allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to acetylsalicylic acid or any other salicylate
- if you have a medical condition that may make you prone to bleeding
- if you have severe kidney and/or liver impairment
Warnings and precautions
Talk to your doctor or pharmacist before you start using Claversal
- if you are or plan to become pregnant
- if you are breast-feeding
- if you have liver or kidney problems
- if you have any lung disease, such as asthma
- if you have been allergic to sulfasalazine in the past
- if you have a stomach or intestinal ulcer
- if you have previously had inflammation of the heart (which could be a consequence of a heart infection)
- if you have ever had a severe skin rash, blistering, or peeling after using mesalazine.
If you experience severe headache or recurrent headache, vision changes, or ringing or buzzing in the ears, contact your doctor immediately.
In case of appearance of any allergic manifestation (e.g., skin rash, itching) or fever during the course of treatment, do not apply more Claversal rectal foam and inform your doctor immediately.
Before and during treatment, your doctor may want to perform regular blood and urine tests to check the functioning of your liver, kidneys, blood, and lungs.
Kidney stones may occur with the use of mesalazine. The symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink enough liquid during treatment with mesalazine.
Severe skin rashes, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN), have been observed with mesalazine treatment. Stop taking mesalazine and seek immediate medical attention if you observe any of the symptoms related to these severe skin reactions described in section 4.
Mesalazine may cause a discoloration of the urine to a reddish-brown color after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.
Children and adolescents
The information on safety in the use of this medicine in children and adolescents is limited.
Do not administer to children under 5 years of age.
Other medicines and Claversal rectal foam
In general, you can continue treatment with other medicines while using Claversal. However, inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine, including those bought without a prescription.
Claversal may interact with other medicines if taken at the same time.
In particular:
- medicines to lower blood sugar (antidiabetics)
- medicines to lower blood pressure (antihypertensives/diuretics)
- medicines for the treatment or prevention of gout attacks
- medicines that help with bowel movements (laxatives containing lactulose)
- medicines to prevent blood clotting (anticoagulants)
- medicines to reduce the activity of the immune system (e.g., azathioprine, 6-mercaptopurine, or thioguanine)
- medicines to treat pain and inflammation (anti-inflammatory agents)
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
There is limited experience with the use of mesalazine during pregnancy and breast-feeding. The newborn may develop allergic reactions after breast-feeding, such as diarrhea. If the newborn develops diarrhea, breast-feeding should be interrupted.
The use of Claversal is not recommended during pregnancy or breast-feeding unless your doctor advises you otherwise.
Driving and using machines
No adverse effects of Claversal on the ability to drive or use machines have been reported.
Claversal rectal foam containssodium metabisulfite, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and glycerol
This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite.
This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
This medicine may cause a mild laxative effect because it contains glycerol.
This medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially sodium-free.
3. How to use Claversal rectal foam
Follow your doctor's instructions for using Claversal exactly, regarding the way and time of using the rectal foam; otherwise, you may not benefit fully from its effects.
In case of doubt, consult your doctor or pharmacist again.
Your doctor will indicate the duration of your treatment with Claversal rectal foam. Do not stop treatment before completion, even if you feel better, as symptoms may return if treatment is stopped too soon.
Strictly follow the treatment according to your doctor's instructions, both in the acute inflammatory phase and in the maintenance time established.
The recommended dose for an adult is:
One to two applications per day (1 to 2 g), for four to six weeks.
Use in children and adolescents
The administration of Claversal to children and adolescents under 18 years of age is not recommended due to the lack of safety and efficacy data.
Do not administer to children under 5 years of age.
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Use in elderly patients
The use of Claversal in elderly patients should be done with caution and limited to those patients with normal renal function.
Claversal 1 g rectal foam is used rectally.
If you use more Claversal than you should
Talk to your doctor if you have used more than prescribed. In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.
If you forget to use Claversal
Do not use a double dose to make up for forgotten doses.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although severe allergic reactions are very rare. If you experience any of these symptoms after using this medicine, stop using this medicine and contact your doctor immediately:
- allergic skin rash;
- fever;
- difficulty breathing.
If you experience fever or irritation of the throat or mouth, stop using this medicine and contact your doctor immediately. These symptoms may be due, very rarely, to a decrease in the number of white blood cells in the blood (a condition called agranulocytosis).
Severe side effects:
Stop taking mesalazine and seek immediate medical attention if you experience any of the following symptoms:
- red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and swollen lymph nodes. These severe skin rashes are often preceded by fever or flu-like symptoms.
- if you experience severe headache or recurrent headache, vision changes, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension)
The following side effects have also been reported in patients using mesalazine:
Rare side effects(may affect up to 1 in 1,000 patients)
- abdominal pain, diarrhea, flatulence, nausea, and vomiting;
- headache, dizziness;
- chest pain, difficulty breathing, or swollen limbs due to an effect on the heart;
- increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)
Very rare side effects(may affect less than 1 in 10,000 patients)
- kidney problems, sometimes with swollen limbs or side pain;
- severe abdominal pain due to acute pancreatitis;
- worsening of colitis symptoms;
- fever, sore throat, or nausea due to changes in blood count;
- difficulty breathing, cough, wheezing, spots on lung X-ray due to allergic and/or inflammatory conditions in the lungs;
- diarrhea and severe abdominal pain due to an allergic reaction to the medicine in the intestine;
- skin rash or inflammation;
- muscle and joint pain;
- jaundice or abdominal pain due to liver or biliary disorders;
- hair loss and development of baldness;
- erythema multiforme;
- numbness and tingling of the fingers and toes (peripheral neuropathy)
- reversible decrease in semen production;
- blood count disorders.
Side effects of unknown frequency(cannot be estimated from the available data).
- kidney stones and associated kidney pain (see also section 2).
Photosensitivity
More severe reactions have been reported in patients with pre-existing skin conditions, such as atopic dermatitis and atopic eczema.
If these symptoms continue or become more severe, talk to your doctor.
Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Claversal rectal foam
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
This pack is a pressurized aerosol that contains a flammable propellant. It should be kept away from any heat source, flames, or sparks, including cigarettes. It should be protected from direct sunlight and not destroyed or burned, even when empty.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.
6. Contents of the pack and further information
Composition of Claversal 1 g rectal foam
- The active ingredient is mesalazine (1g per application)
- The other ingredients (excipients) are: sorbitan monooleate, polysorbate 20, emulsifying wax, anhydrous colloidal silica, sodium metabisulfite (E-223), disodium edetate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, glycerol, polyethylene glycol 300, purified water, propane, iso-butane, and n-butane.
Appearance of the product and pack contents
Rectal foam for administration. The foam is white to light brown in color.
The pack includes:
- 1 aerosol that dispenses 14 applications,
- a kit consisting of a base or grid with 14 compartments (containing a small amount of petroleum jelly), and 14 disposable applicators are inserted into these compartments. The purpose of the petroleum jelly is to facilitate the introduction of the applicators into the rectum,
- 14 disposable plastic bags,
- a patient information leaflet.
Marketing authorization holder
Faes Farma, S.A.
Autonomia Etorbidea, 10
48940 Leioa (Bizkaia)
Spain
Manufacturer
SOFAR
Via Firenze, 40
20060 Trezzano Rosa, Milan
Italy
Date of last revision of this leaflet:January 2025
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/
- Country of registration
- Dosage formRECTAL SEMISOLID, 1000 mg
- ATC codeA07EC02
- Average pharmacy price21.76 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- CompositionHIDROGENOFOSFATO DE SODIO DODECAHIDRATO (0,064 g mg), GLICEROL (E 422) (0,680 g mg), PARAHIDROXIBENZOATO DE METILO (E-218) (0,011 g mg), DIHIDROGENOFOSFATO DE SODIO DIHIDRATO (0,028 g mg), EDETATO DE DISODIO (0,006 g mg), SORBITAN MONOOLEATO (0,011 g mg), SODIO, METABISULFITO DE (E 223) (0,014 g mg), CERA EMULSIFICANTE (0,023 g mg), POLISORBATO 20 (0,415 g mg), PARAHIDROXIBENZOATO DE PROPILO (0,002 g mg)
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to CLAVERSAL ESPUMA RECTAL (Rectal Foam)Dosage form: SUPPOSITORY, 1 gActive substance: mesalazineManufacturer: Tillotts Pharma Spain S.L.U.Prescription requiredDosage form: TABLET, 1600 mgActive substance: mesalazineManufacturer: Tillotts Pharma Spain S.L.U.Prescription requiredDosage form: TABLET, 400 mgActive substance: mesalazineManufacturer: Tillotts Pharma Spain S.L.U.Prescription required
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Frequently Asked Questions
CLAVERSAL ESPUMA RECTAL (Rectal Foam) requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in CLAVERSAL ESPUMA RECTAL (Rectal Foam) is mesalazine. This information helps identify medicines with the same composition but different brand names.
The average pharmacy price for CLAVERSAL ESPUMA RECTAL (Rectal Foam) is around 21.76 EUR. Prices may vary depending on the manufacturer and dosage form.
CLAVERSAL ESPUMA RECTAL (Rectal Foam) is manufactured by Faes Farma S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CLAVERSAL ESPUMA RECTAL (Rectal Foam) is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy CLAVERSAL ESPUMA RECTAL (Rectal Foam) in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (mesalazine) include ASACOL 1 G SUPPOSITORIES, ASACOL 1600 mg GASTRO-RESISTANT TABLETS, ASACOL 400 mg GASTRO-RESISTANT TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
